Risk Evaluation Assessor - Musculoskeletal, Trauma and Cosmetic

Overview

Senior Benefit Risk Evaluation Assessor – Musculoskeletal, Trauma and Cosmetic to join the Benefit/Risk Evaluation Team II Function within the Safety and Surveillance group. This is a full-time, permanent role based at 10 South Colonnade, Canary Wharf London, E14 4PU
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We are implementing a flexible, hybrid way of working with a minimum of 8 days per month on site to enable collaboration with partners and stakeholders. Attendance on site is driven by business needs and can flex up to 12 days a month; the remainder may be remote or in the office. Some roles may require more regular on-site presence.

The Medicines and Healthcare products Regulatory Agency enhances and improves health through the regulation of medicines and medical devices, underpinned by science and research. The Safety and Surveillance Group combines devices and medicines safety expertise with enforcement capabilities and is supported by data/evidence generation and the Safety Connect System.

The Musculoskeletal, Trauma and Cosmetic Benefit Risk Evaluation team monitors safety across these therapy areas, including orthopaedic devices (e.g., hip and knee replacements), cosmetic and plastic devices (e.g., breast implants), and wound care products used in trauma. The team also covers medicines such as botulinum toxin used for cosmetic purposes, musculoskeletal gene therapy, and creams/ointments for wound care.

The core purpose is to provide robust benefit-risk assessments of potential safety signals in the Musculoskeletal, Trauma and Cosmetic therapeutic area using data from diverse sources and applying technical, scientific, clinical and regulatory knowledge and/or practical experience. Responsibilities include engaging with patients, the public and other stakeholders to deliver timely, robust benefit-risk assessments and to recommend safety actions and risk mitigations that are outcome-focused.

While the focus is on medical devices, there are opportunities to work across medicines and medical devices.

The Benefit Risk Assessor will contribute to ongoing work and help increase capacity to respond to new and emerging safety issues. They will have comprehensive medical device regulatory experience and professional, technical or scientific expertise in the Musculoskeletal, Trauma and Cosmetic therapeutic area. The experience of the successful applicant will help onboard new team members and build their competencies.

• Lead, influence or deliver high-quality critical appraisals/assessments for significant safety or risk:benefit issues, evaluating all relevant information sources including real-world evidence, within agreed timelines, seeking expert advice as needed and ensuring patient experience is considered
• Actively engage with patients, the public, external stakeholders, government departments, professional bodies and the wider health sector
• Develop communications for the public, senior officials or ministers and provide scientific, technical and clinical input to ensure timely advice to healthcare professionals
• Lead and develop cross-portfolio projects, identify and deploy resources, and mentor junior staff to achieve agency patient safety goals

• Have comprehensive experience in critically analysing clinical/scientific information from diverse sources (case reports, registries, trials/investigations, observational studies) to make sound recommendations protecting patient safety and public health
• Have in-depth knowledge and experience of relevant regulations and procedures applicable to medical devices
• Have therapeutic and/or technical expertise relevant to the Musculoskeletal, Trauma and Cosmetic Benefit-Risk Evaluation team
• Have excellent interpersonal skills to facilitate teamwork and leadership, and to collaborate with colleagues from different disciplines
• Share knowledge to improve team capability within the safety and surveillance function

Method of assessment: A=Application, I=Interview, P=Presentation

• Making Effective Decisions (A, I)
• Delivering at Pace (A, I)
• Communicating and Influencing (A, I, P)
• Working Together (A, I, P)

• Excellent written and verbal communication skills; ability to write authoritative reports and deliver presentations (A, I, P)
• Excellent interpersonal skills to facilitate teamwork and leadership across disciplines
• Comprehensive experience with relevant medical device regulations and procedures (A, I, P)
• Relevant therapeutic/technical knowledge for the Musculoskeletal, Trauma and Cosmetic team (A, I)
• Analytical capability with diverse sources of clinical/scientific information to make sound safety recommendations (A, I)

• A degree in a relevant health, scientific or engineering discipline (e.g., medicine, biochemistry, physiology, medical engineering or regulation) (A)
• In-depth knowledge of medical device regulations and the MHRA role in Benefit Risk…